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510(k) Data Aggregation

    K Number
    K081466
    Device Name
    STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2008-07-30

    (64 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K122727
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Sterile, Powder Free Nitrile Examination Gloves, Blue

    AI/ML Overview

    I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Sterile, Powder Free Nitrile Examination Gloves, Blue." It does not contain information about acceptance criteria or a study that proves a device meets such criteria. Therefore, I cannot fulfill your request for that specific information based on the input given.

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